Associate Clinical Research Manager

MSD; Selangor; On-site; MYR 120,000 - 190,000; Full time

Job summary

MSD in Malaysia seeks an experienced professional to manage end-to-end performance of clinical study protocols. You will act as liaison between Country Operations and the Clinical Trial Team, ensuring regulatory and quality compliance across studies.

Responsibilities include planning, tracking deliverables, risk management, and collaboration with CTCs, CRAs, COMs plus external partners. Travel up to 30% may be required to support regional trials.

Qualifications

• Bachelor's degree in science or related field.
• Minimum four years' experience in clinical research.
• CRA experience preferred.

Responsibilities

• Serve as primary POC for assigned protocols between Country Operations and the Clinical Trial Team.
• Oversee end-to-end project management from feasibility to closeout and track timelines.
• Ensure protocol compliance with regulations, policies, and quality standards.
• Review MVRs, escalate issues, and conduct QCVs as needed.
• Lead local study teams with training and coordination across country functions.

Skills

Project management

Site management

Stakeholder management

English communication

Local language

AI fluency

Education

Bachelor's Degree in Science

Job description

This role is primarily responsible for the end-to-end performance and project management of assigned clinical study protocols within a country, ensuring compliance with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

The aCRM may be responsible for managing a specific study across multiple countries, including Malaysia, Singapore, and/or Indonesia.

Key Responsibilities

• Serve as the primary point of contact (POC) for assigned protocols and act as the liaison between Country Operations and the Clinical Trial Team (CTT).
• Oversee project management activities for assigned studies, including planning, execution, tracking deliverables, timelines, and study performance from feasibility through closeout.
• Ensure protocol performance and compliance with applicable regulations, policies, procedures, and quality standards.
• Review Monitoring Visit Reports (MVRs) and escalate performance issues or training needs when required.
• Conduct Quality Control Visits (QCVs) as needed.
• Lead and support local study teams by providing protocol expertise, training, and coordination across country functions, including Clinical Trial Coordinators (CTCs), Clinical Research Associates (CRAs), and Clinical Operations Managers (COMs).
• Develop and execute local risk management plans for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key clinical systems.
• Escalate study-related challenges and risks to appropriate stakeholders as needed.
• Identify and share best practices across studies, countries, and regional teams.
• Collaborate with outsourcing vendors, investigators, and external partners.
• Serve as the country contact for programmatically outsourced trials.
• Build and maintain strong relationships with investigators and external stakeholders.
• Support local business needs, including contract and budget management where delegated.
• Contribute to local and regional strategy development.
• Partner with global, regional, and local stakeholders including Clinical Operations, Pharmacovigilance, and Medical Affairs to drive study success.

Skills & Competencies

• Strong knowledge of project management and/or site management.
• Excellent organizational and prioritization skills.
• Ability to work independently and make informed decisions within established policies and guidelines.
• Strong understanding of the local regulatory environment.
• Scientific and clinical research knowledge.
• Understanding of clinical trial planning, management, and performance metrics.
• Ability to manage multiple studies and competing priorities simultaneously.
• Strong stakeholder management and collaboration skills.
• Effective communication skills in both written and spoken English and the local language.
• Strategic thinking and problem-solving capability.
• Ability to work effectively in remote and virtual environments.
• Emerging leadership capabilities with the ability to influence and align stakeholders.
• Proactive identification of risks, issues, and opportunities, with the ability to develop mitigation plans.
• Strong negotiation and conflict-resolution skills.
• Excellent diplomacy, relationship-building, and interpersonal skills.
• AI fluency.

Qualifications & Experience

• Bachelor's Degree in Science or a related discipline.
• Minimum 4 years of experience in clinical research.
• Clinical Research Associate (CRA) experience preferred.

Travel Requirement

• Up to 30% travel required.

Required Skills: Adaptability, Adaptability, Clinical Research, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Conflict Management, Cross-Cultural Awareness, ICH GCP Guidelines, Knowledge Management, Negotiation, Organizational Leadership, Outsourcing, Patient Recruitment, Process Management, Project Delivery, Project Development, Project Management Methodology (PMM), Project Planning, Project Scoping {+ 7 more}

At MSD, our focus on developing novel medicines and vaccines that address unmet medical needs distinguishes us as one of the world’s leading research-driven pharmaceutical companies. Join us and experience our culture first-hand; one of strong ethics and integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

History

Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.

We made our first steps towards meeting the needs of patients in Malaysia almost 45 years ago, in 1965. Today, Malaysia is one of 13 subsidiaries within the MSD Asia Pacific region. For more information, visit www.msd-malaysia.com